Analytical Method Validation Services – Ghana

Ensuring Accuracy. Compliance. Regulatory Confidence for Ghana Regulatory Submissions

VALIDEX, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Analytical Method Validation (AMV) services for Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Finished Products, fully compliant with Ghanaian regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Ghana with FDA Ghana–compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Food and Drugs Authority (FDA Ghana) queries for product registration, marketing authorization, manufacturing/import approvals, and export dossiers.

Our Core Expertise – Ghana Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Food and Drugs Authority (FDA Ghana) under the Ministry of Health, Republic of Ghana.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by FDA Ghana
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / EP / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with FDA Ghana & WHO expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial impurity limits

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with FDA Ghana product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by FDA Ghana
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision

Products Covered – Ghana

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders, sachets)
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid & liquid dosage forms
✅ Modified-release and controlled-release products

Regulatory Compliance – Ghana

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• FDA Ghana Registration Guidelines & Technical Requirements
• Public Health Act, 2012 (Act 851)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by FDA Ghana)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Ghana

VALIDEX provides complete FDA Ghana query management, including:

✅ Responses to FDA Ghana deficiency letters and technical evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during FDA Ghana dossier reviews, inspections, and audits

Why Choose VALIDEX for Ghana?

✔ Strong understanding of FDA Ghana regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Ghana
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Ghana

• Analytical Method Validation Protocols (FDA Ghana–compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Non-CTD summary documents for FDA Ghana submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Ghana

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms

National & Export Support – Ghana

VALIDEX supports Analytical Method Validation for:

• Ghana domestic product registration (FDA Ghana)
• Manufacturing and import authorization applications
• Export dossiers prepared for FDA Ghana-regulated and WHO-referenced markets

Partner with VALIDEX – Ghana

Achieve FDA Ghana–ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Ghana.